欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
DK/H/2279/003
药品名称
Lesamor
活性成分
hydrochlorothiazide 25.0 mg
telmisartan 80.0 mg
剂型
Tablet
上市许可持有人
Stada Arzneimittel AG Stadastrasse 2-18 61118 - Bad Vilbel Germany
参考成员国 - 产品名称
Denmark (DK)
Lesamor
互认成员国 - 产品名称
许可日期
2013/11/14
最近更新日期
2023/12/04
药物ATC编码
C09DA07 telmisartan and diuretics
申请类型
TypeLevel1:
Abridged
TypeLevel2:
Additional Strength/Form
TypeLevel3:
Generic Art 10.1 and 10.2 Dir 2001/83/EC
TypeLevel4:
Chemical Substance
TypeLevel5:
Prescription Only
附件文件下载
Final Labelling
|
1_3_1_LABcomb_COM_TelmHCT2279_Var005_CLEAN
Date of last change:2024/09/06
Final Product Information
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1_3_1_SPC_COM_TelHCT_2278_V004D30_cl
Date of last change:2024/09/06
Final Product Information
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1_3_1_SPC_COM_TelHCT_2279_V003D30_clean
Date of last change:2024/09/06
Final Product Information
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1_3_LABcomb_COM_TelmHCT2279_Var003_cl
Date of last change:2024/09/06
Final Product Information
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1_3_LABcomb_TelmHCT2278_Var004_cl _1_
Date of last change:2024/09/06
Final Product Information
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1_3_PIL_COM_TelHCT_2279_V003_cl
Date of last change:2024/09/06
Final Product Information
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1_3_PIL_COM_TelmHCT2278_Var004_cl
Date of last change:2024/09/06
PubAR
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Final PAR Scientific discussion Lesamor DKH2279_001_003_DC
Date of last change:2024/09/06
Final PL
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Lesamor Common PIL _ clean
Date of last change:2024/09/06
Final SPC
|
Lesamor Common SmPC _ clean
Date of last change:2024/09/06
PubAR Summary
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sPAR_20Telmisartan_HCT_20DK_H_2279_1_
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase